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Single-dose oral ivermectin in mild and moderate COVID-19 (RIVET-COV): a single-centre randomized, placebo-controlled trial

Mohan et al., Journal of Infection and Chemotherapy, doi:10.1016/j.jiac.2021.08.021 (date from preprint), RIVET-COV, CTRI/2020/06/026001

Feb 2021

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RCT in India with low risk patients, comparing 24mg ivermectin, 12mg ivermectin, and placebo showing non-statistically significant improvements in recovery and PCR+ status (day 5 both arms, day 7 24mg only) with treatment, and showing greater improvement for the higher dose arm. Viral load decline was similar in all arms - absolute values are lower for ivermectin in a dose-dependent manner, however the baseline value for the ivermectin groups was lower, leaving less room for change. There were no deaths or use of mechanical ventilation. There were no serious adverse events. Note that our pre-specified protocol prioritizes clinical outcomes over PCR results.

Viral load measured by PCR may not accurately reflect infectious virus measured by viral culture. Porter show that viral load early in infection was correlated with infectious virus, but viral load late in infection could be high even with low or undetectable infectious virus. Assessing viral load later in infection may underestimate reductions in infectious virus with treatment.

This is the 16th of 46 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000014.

This is the 35th of 99 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 2 sextillion).

1. Porter et al., The ratio between SARS-CoV-2 RNA viral load and culturable viral titer differs depending on stage of infection, medRxiv, doi:10.1101/2023.07.06.23292300.medrxiv.org, doi.org.

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risk of no discharge at day 14, 62.5% lower, RR 0.38, p = 0.27, treatment 2 of 40 (5.0%), control 6 of 45 (13.3%), NNT 12, 24mg.

risk of no discharge at day 14, 43.8% lower, RR 0.56, p = 0.49, treatment 3 of 40 (7.5%), control 6 of 45 (13.3%), NNT 17, 12mg.

risk of clinical worsening, 32.5% lower, RR 0.68, p = 0.72, treatment 3 of 40 (7.5%), control 5 of 45 (11.1%), NNT 28, 24mg.

risk of clinical worsening, 55.0% lower, RR 0.45, p = 0.44, treatment 2 of 40 (5.0%), control 5 of 45 (11.1%), NNT 16, 12mg.

risk of no viral clearance, 23.8% lower, RR 0.76, p = 0.18, treatment 21 of 40 (52.5%), control 31 of 45 (68.9%), NNT 6.1, day 5, 24mg, primary outcome.

risk of no viral clearance, 5.6% lower, RR 0.94, p = 0.82, treatment 26 of 40 (65.0%), control 31 of 45 (68.9%), NNT 26, day 5, 12mg.

risk of no viral clearance, 10.3% lower, RR 0.90, p = 0.65, treatment 20 of 36 (55.6%), control 26 of 42 (61.9%), NNT 16, day 7, 24mg.

risk of no viral clearance, 3.2% higher, RR 1.03, p = 1.00, treatment 23 of 36 (63.9%), control 26 of 42 (61.9%), day 7, 12mg.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Mohan et al., 2 Feb 2021, Double Blind Randomized Controlled Trial, India, peer-reviewed, 27 authors, study period 28 July, 2020 - 29 September, 2020, average treatment delay 5.0 days, dosage 400μg/kg single dose, 200μg/kg also tested, trial CTRI/2020/06/026001 (RIVET-COV).

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Single-dose oral ivermectin in mild and moderate COVID-19 (RIVET-COV): A single-centre randomized, placebo-controlled trial

Prof Anant Mohan, Tejas Pawan Tiwari, Tejas Menon Suri, Saurabh Mittal, Ankit Patel, Ujjalkumar Avinash Jain, Thirumurthy Velpandian, Ujjalkumar Subhash Das, Tarun Krishna Boppana, Sushil Ravindra Mohan Pandey, Sushil Suresh Shelke, Angel Rajan Singh, Sushma Bhatnagar, Shet Masih, Shelly Mahajan, Tanima Dwivedi, Biswajeet Sahoo, Anuja Pandit, Shweta Bhopale, Saurabh Vig, Ritu Gupta, Karan Madan, Vijay Hadda, Nishkarsh Gupta, Rakesh Garg, Ved Prakash Meena, Randeep Guleria

Journal of Infection and Chemotherapy, doi:10.1016/j.jiac.2021.08.021

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

CONFLICTS OF INTEREST: None to declare

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